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Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782470
First Posted: October 31, 2008
Last Update Posted: November 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Condition Intervention
Hematologic Disease Blood Coagulation Disorders Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • To evaluate the frequency of all bleeds (spontaneous and trauma) during the study [ Time Frame: End of Study ]

Secondary Outcome Measures:
  • To evaluate the change from baseline in HRQoL (health-related quality of life) [ Time Frame: End of Study ]
  • To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy [ Time Frame: End of Study ]
  • To evaluate the change from baseline in the Gilbert score [ Time Frame: End of Study ]
  • To evaluate the number of target joint development [ Time Frame: End of Study ]

Enrollment: 38
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects electing to stay on the prophylactic treatment (prospective)
Group 2 Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects electing to switch to on-demand treatment (prospective)
Group 3 Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects remaining on-demand treatment (retrospective)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 - Retrospective On-demand Group
Criteria

Inclusion Criteria:

  • Severe hemophilia A (<2%)
  • For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
  • For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
  • For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
  • Current treatment with rFVIII

Exclusion Criteria:

  • Other known hematological / bleeding disorders other than hemophilia A
  • Participating on another study that may have an impact on bleeding or the objectives of this study
  • Known alcohol and drug abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782470


Locations
United States, California
Duarte, California, United States, 91010
United States, Colorado
Denver, Colorado, United States, 80262
United States, Illinois
Peoria, Illinois, United States, 61614
United States, Missouri
Jefferson City, Missouri, United States, 65109
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, Texas
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
Canada
Many Locations, Canada
Germany
Many Locations, Germany
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00782470     History of Changes
Other Study ID Numbers: 12749
First Submitted: October 29, 2008
First Posted: October 31, 2008
Last Update Posted: November 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hemophilia A
Hematologic Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants